Study of transgender and non-binary individuals living with HIV in Europe
Trans People Living With HIV Throughout Europe
This study looks at how well HIV treatment works for transgender and non-binary people living with HIV in Europe and what challenges they face in sticking to their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chelsea and Westminster NHS Foundation Trust Academic / other |
| Drugs / interventions | cART |
| Locations | 4 sites (Torino and 3 other locations) |
| Trial ID | NCT03922269 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on a cohort of transgender and non-binary individuals living with HIV across Europe. Over an 18-month period, it will collect both qualitative and clinical data, including HIV viral load measurements from routine blood tests. The study aims to assess the effectiveness of antiretroviral therapy in this population and explore various factors such as demographics, risk behaviors, and barriers to treatment adherence. The findings will help inform future HIV treatment guidelines and interventions tailored to the needs of transgender and non-binary individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 and older who identify as transgender or non-binary and are living with HIV.
Not a fit: Patients who are under 18 years old or do not identify as transgender or non-binary will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved HIV treatment guidelines specifically designed for transgender and non-binary individuals.
How similar studies have performed: While there have been studies focusing on HIV treatment in diverse populations, this specific approach targeting transgender and non-binary individuals is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people) * Age \> 18 years * HIV infection diagnosis at any time before study consent * Having been prescribed antiretroviral therapy at any time (including people for who antiretroviral therapy initiation is planned after study enrolment) * Willing to sign an informed consent and take part in the study Exclusion Criteria: * Age \< 18 years * Unable to take part in the study according to the Investigator opinion (example: unable to understand the study information leaflet, unable to provide written consent, etc.)
Where this trial is running
Torino and 3 other locations
- Servizio Sanitario Nazionale Regione Piemonte Azienda Sanitaria Locale "Citta di Torino" Department of Medical Sciences, University of Turin — Torino, Italy (Recruiting)
- Chelsea and Westminster Hospital — London, Greater London, United Kingdom (Recruiting)
- Manchester University NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (Recruiting)
- Elton John Centre, Brighton and Sussex University Hospitals — Brighton, Sussex, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Marta Boffito, MD, PhD — Chelsea and Westminster NHS Foundation Trust
- Study coordinator: Research Delivery Operations Manager
- Email: research.development@chelwest.nhs.uk
- Phone: 020 3315 6825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.